Status:
RECRUITING
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Relapsed or Refractory Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years at the time of signing informed consent;
- Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies;
- Presence of measurable or evaluable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
- Contraceptives or other approved avoidance of pregnancy measures
Exclusion
- Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;
- Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);
- Undergone major surgery ≤ 2 weeks prior to starting study drug;
- Evidence of mucosal or internal bleeding;
- Impaired cardiac function or conduction defect;
- Concurrent severe and/or uncontrolled medical conditions
Key Trial Info
Start Date :
September 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03838926
Start Date
September 27 2018
End Date
December 1 2025
Last Update
July 17 2025
Active Locations (11)
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1
Vanda Investigational Site
Washington D.C., District of Columbia, United States, 20007
2
Vanda Investigational Site
Lafayette, Indiana, United States, 47905
3
Vanda Investigational Site
Hackensack, New Jersey, United States, 07601
4
Vanda Investigational Site
Seattle, Washington, United States, 98109